Study information

Scientific title

Acronym

Study hypothesis

Multiparametric ultrasound has a comparable performance to multiparametric MRI in the detection and risk stratification of prostate lesions that warrant biopsy.

Ethics approval

London (Brent East), 8/10/2015, ref: 15/LO/1331

Study design

Prospective multi-centre cohort diagnostic utility study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not currently available in web format. The PIS may be requested from CADMUS@uclh.nhs.uk

Condition

Prostate cancer

Intervention

Men who require a prostate biopsy will be approached and consented to enter this study. Participants will all undergo pre-biopsy mp-MRI (reference test) and mp-USS (index test) of the prostate. Only men with positive scans will undergo prostate biopsy. The order in which lesions discovered on mp-MRI or on mp-USS are sampled will be randomised. All biopsies will be taken via the transperineal route in a single procedure. Comparison will be drawn between biopsy results of lesions detected by mp-USS with those lesions detected by mp-MRI. Consideration will be given as to whether a lesion detected by one imaging modality is the same abnormality as one detected by the other imaging modality, in the same patient. Analysis will be carried out at both the level of the lesion and the whole prostate. Men without suspicious lesions on either imaging modality will not proceed to biopsy. The first 20 patients recruited will comprise an internal pilot to ensure we are carrying out high quality mp-USS studies.

Intervention type

Device

Phase

Drug names

Primary outcome measures

The proportion of men with a lesion detected using each diagnostic strategy and the proportion of men subsequently diagnosed with clinically significant prostate cancer as defined histologically as UCL/Ahmed definition 1 (Gleason 4+3 or greater and/or maximum cancer core length of 6mm or greater).

Secondary outcome measures

1. The proportion of men diagnosed with clinically significant prostate cancer by each diagnostic strategy as defined histologically using other thresholds for clinical significance, namely:1.1. UCL/Ahmed definition 2: Gleason >3+4 and/or Maximum cancer core length >4mm1,2. Gleason >3+4 and/or MCCL >6mm1.3. Any length of Gleason >3+41.4. Any length of Gleason >4+32. The proportion of men diagnosed with clinically significant cancer (using all of the pre-specified definitions based on histology) by using the combination of these two imaging techniques versus either modality alone. 3. The proportion of men diagnosed with clinically significant prostate cancer (using all of the pre-specified definitions based on histology) when:3.1. mp-USS targeted biopsies are carried out first compared to being carried out second and when order in which the targeted biopsies are carried out3.2. mp-MRI targeted biopsies are carried out first compared to being carried out second4. The proportion of men from the cohort who progress to radical prostatectomy, and have whole mount histology that matches the results of the mp-USS, mp-MRI and targeted biopsy.5. Proportions of adverse events, log of resource utilization and health-related quality-of-life measures on the EQ-5D-5L questionnaire6. A cohort of men, consented for long-term follow-up and linkage, providing the potential for further translational and clinical studies

Overall trial start date

01/12/2014

Overall trial end date

01/02/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. A potential need for prostate biopsy indicated by raised PSA or other clinical parameter, the final decision over which will be taken after imaging. 2. PSA </=20ng/ml measured within 6 months of screening visit3. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process4. Estimated life expectancy of 5 years or more5. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

500 approx.

Participant exclusion criteria

1. Any contraindication to the ultrasound contrast agent including right to left shunt, pulmonary hypertension and uncontrolled hypertension. Also patients with an acute coronary syndrome within the last 6 months or ischaemic heart disease that’s not well controlled by medication. 2. Any form of androgen deprivation or hormones (except 5-alpha reductase inhibitors) within 6 months of screening visit3. Irreversible coagulopathy predisposing to bleeding4. Inability to undergo transrectal ultrasonography5. Prostate volume, measured at the time of mp-USS if previously unknown, of >60cc. 6. Previous radiation therapy to the prostate7. Previous HIFU, cryosurgery, thermal therapy, irreversible electroporation, photodynamic, photothermal therapy, microwave or injectable toxin therapy to the prostate. 8. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality within 6 months of screening visit 9. Nodal or metastatic prostate cancer on any form of imaging at any time-point10. Not fit for general anaesthetic11. Unable to give informed consent12. Any other condition the investigator considers would make the patient unsuitable

Recruitment start date

01/03/2016

Recruitment end date

01/01/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College Hospital London
235, Euston Rd
Fitzrovia
London
NW1 2BU